Attachment Device for a Tracheostoma Valve

ABSTRACT

An attachment device for a tracheostoma valve has a flexible layer structure having a stoma opening therein, and a circumferential flange attached to the flexible layer structure. The flexible layer structure has at least a layer portion that substantially has a funnel shape discharging into the stoma opening. A circumferential attachment area, where the flexible layer structure is attached to the circumferential flange, is situated at a distance from a circumferential edge of the stoma opening. Part of the funnel shape extends between the circumferential attachment area and the circumferential edge of the stoma opening.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a is a continuation of U.S. application Ser. No.13/262,465 with a 371(c) date of Dec. 23, 2011, now allowed, which is aUnited States national phase application of international patentapplication number PCT/NL2010/050165, filed Mar. 31, 2010, which claimsthe benefit of EP Application No. 09157110.9 filed Apr. 1, 2009 and U.S.Provisional Application No. 61/180,956 filed May 26, 2009, each of whichis hereby incorporated by reference in its entirety.

BACKGROUND

The invention relates to a tracheostoma valve comprising a main airpassage structure provided with a main valve arrangement.

Severe cancer in the laryngeal or hypopharyngeal region often requires atotal laryngectomy, i.e. excision of the larynx (including vocal folds).Reconstruction is performed by leading the trachea outside. The tracheathen ends in an opening in the neck, the so-called “tracheostoma”. Afterthis operation, voice restoration usually takes place bytracheo-oesophageal puncture and the insertion of a one-way valve(“shunt valve”) in the puncture. In other words, such a shunt valve isinserted in the wall between the trachea and the oesophagus. By closingthe tracheostoma (manually or by means of a so-called “tracheostomavalve”), exhalation air flows through the shunt valve to an air chamberenclosed by soft tissue at the top of the oesophagus, which then startsto vibrate and acts as new “vocal folds”.

One of the major problems for the patient who has undergone alaryngectomy and voice rehabilitation concerns the tracheostoma. Thetracheostoma attracts attention, especially when the patient has toclose it with a thumb or finger in order to speak. Also, stoma closurecan be unhygienic and impractical when the patient's hands are dirty.Manual tracheostoma closure is also impossible during certainactivities, e.g., while driving a car, eating, or participating insports. Therefore, several tracheostoma valves have been developed in anattempt to overcome these problems related to manual tracheostomaclosure.

Such tracheostoma valves are switchable from a breathing condition intoa speaking condition, and vice versa. In the breathing condition themain valve arrangement is in an open position allowing air inhalationand exhalation via the main air passage structure. In the speakingcondition the main valve arrangement is in a closed position preventingat least air exhalation via the main air passage structure.

The earliest known tracheostoma valves are of a type in which thetracheostoma valve can be switched, in response to a spurt of exhalationair, from said breathing condition into said speaking condition, whilethe tracheostoma valve switches back, in response to inhalation, fromsaid speaking condition into said breathing condition. This type ofknown tracheostoma valves (herein referred to as “exhalation valves”)has several drawbacks, such as the following. A portion of theexhalation air that is needed for bringing the valve in speakingcondition can not be used anymore for speech production. When one has toinhale again, the valve changes from speaking condition into breathingcondition. For continuation of speech, the valve then has to be broughtin speaking condition again. Furthermore, such exhalation valves areexpensive and susceptible to maintenance because they consist of manyparts. They are difficult to operate (small knobs for setting), large,heavy, conspicious and hard to the touch.

More recently, in an attempt to overcome some of these drawbacks, therehas been developed another tracheostoma valve type. For this other type,the tracheostoma valve is switchable, in response to a spurt ofinhalation air, from said breathing condition into said speakingcondition, while the tracheostoma valve is switchable, in response to aspurt of exhalation air, from said speaking condition into saidbreathing condition. The advantage of this other type of knowntracheostoma valves (herein referred to as “inhalation valves”) is thatall exhalation air is available for speech. Moreover, inhalationprecedes speaking, which makes speech more natural. Such a knowninhalation valve is disclosed in EP1025874.

The inhalation valve known from EP1025874 has a further advantage inthat it provides an ability to inhale during phonation, allowing thepatient to extend the duration of speech indefinitely. Hence, this knowninhalation valve can automatically stay in the speaking condition untilthe patient deliberately changes it into the breathing condition. Theability to inhale during phonation is realized in that this knowninhalation valve comprises a one-way bypass valve member which in saidspeaking condition allows for air inhalation therethrough, but preventsair exhalation therethrough.

Though the known inhalation valve thus solves some importantdisadvantages of the exhalation valve, the known inhalation valve stillhas several drawbacks. For example, it is still expensive andsusceptible to maintenance because it consist of many parts, it is stilldifficult to operate (small knobs for setting), large, heavy,conspicious and hard to the touch.

SUMMARY

It is an object of the invention to provide at least an alternativetracheostoma valve of said “inhalation” type, and, preferably, toprovide such an alternative tracheostoma valve which offers improvementswith respect to simplicity and/or compactness and/or reliability and/orsoftness.

For that purpose, the invention provides a tracheostoma valve accordingto claim 1. Hence, a tracheostoma valve according to the invention is ofsaid “inhalation valve” type, wherein its main valve arrangementcomprises an at least partly flexible bistable wall portion which has acircumferential bordering edge, wherein at least part of thecircumferential bordering edge forms a hinging means around which thebistable wall portion is hingeable between a first stable position inwhich said closed position of the main valve arrangement is attained inthat an orifice of the main air passage structure is being blocked, anda second stable position in which said open position of the main valvearrangement is attained in that said orifice is released.

Because of said co-operating bistable wall portion and orifice there areonly few and simple parts for realizing the main valve arrangement,rendering compactness and low susceptibility to maintenance.Furthermore, the bistable character of the valve arrangement rendersadditional reliability of the arrangement. The said flexibility of thebistable wall portion contributes to softness of the tracheostoma valve.

As an intermezzo, it is remarked that U.S. Pat. No. 5,392,775 disclosesa tracheostoma valve 10 having some features in common with atracheostoma valve according to the present invention. More inparticular, the known tracheostoma valve 10 has a main valve arrangementcomprising a duckbill valve 16 having a flexible bistable wall portion17. This flexible portion 17 has a circumferential bordering edge, whichforms a hinging means around which the portion 17 is hingeable betweentwo stable positions.

However, the known valve 10 is not a valve of the abovementioned“inhalation” type, since it is not switchable in response to a spurt ofinhalation air from the abovementioned breathing condition into theabovementioned speaking condition in the sense of a tracheostoma valveaccording to the present invention. Instead, when starting off from itsbreathing condition as shown in FIG. 5 of U.S. Pat. No. 5,392,775, theknown valve 10 switches in response to a spurt of inhalation air intoone of the conditions as shown in FIG. 3 or FIG. 2 of U.S. Pat. No.5,392,775. In these conditions of FIG. 3 or 2 the main valve arrangementis not in a closed position and air exhalation is not prevented via themain air passage structure, because of the presence of the air flowpassage 59 defined by the two flexible edges 19, 21 of the flexibleportion 17. In fact, when starting off from the condition as shown insaid FIG. 2, such air exhalation is prevented not until pressuredifferences resulting from exhalation air have forced the two flexibleedges 19, 21 together so as to form a seal 29 shown in the condition ofFIG. 4 of U.S. Pat. No. 5,392,775. Thus, only said FIG. 4 represents aspeaking condition in the sense of a tracheostoma valve according to thepresent invention. Because of this delayed prevention of air exhalationvia the main air passage structure, the known valve 10 suffers fromdrawbacks which are similar to those of the valves of the “exhalation”type as defined and discussed above. That is, in each exhalation strokeoccurring during a speech session a portion of exhalation air, leakingthrough the air flow passage 59 and needed for bringing the valve 10 inthe speaking condition of said FIG. 4, is wasted in the sense that itcan not be used anymore for speech production.

A further difference between the known valve 10 and a valve according tothe invention is explained as follows. The only two positions in whichthe flexible portion 17 of the known valve 10 is stable are the “normalresting position 31” shown in FIG. 2 of U.S. Pat. No. 5,392,775 and the“inverted position” shown in FIG. 5 of U.S. Pat. No. 5,392,775. Notethat the position shown in FIG. 4 of U.S. Pat. No. 5,392,775 is notstable. In fact, the position of FIG. 4 merely exists by the grace ofexternal conditions, more specifically the external flow conditions inthe form of exhalation air flow that creates the pressure differencesforcing the two flexible edges 19, 21 together. In absence of suchexhalation air flow, the flexible portion 17 automatically returns toits stable position of FIG. 2. In the stable, normal resting position 31shown in FIG. 2 air is free to flow in opposing directions through theair flow passage 59 defined by the two flexible edges 19, 21 of theflexible portion 17. In contrast, for a valve according to theinvention, the position of the bistable wall portion in which the closedposition of the main valve arrangement is attained is a stable position.

In addition to the mentioned drawback relating to wasting portions ofexhalation air not available for speech production anymore, the knownvalve 10 suffers from the further drawback that it is relativelyspacious. Especially when seen in axial direction of the tubular section11 to which the flexible portion 17 is mounted, the flexible portion 17takes up a lot of space not only in its normal positions (FIGS. 2-4 ofU.S. Pat. No. 5,392,775), but also in its inverted position (FIG. 5 ofU.S. Pat. No. 5,392,775). This makes the known tracheostoma valve 10,which is based upon the duckbill valve 16, generally impractical fordaily use by patients having undergone laryngectomy and reconstruction.

Herewith, the intermezzo regarding the discussion of the tracheostomavalve known from U.S. Pat. No. 5,392,775 is concluded, and we now revertto further aspects of a tracheostoma valve according to the presentinvention.

Preferably, the bistable wall portion is an integrated part of an atleast partly flexible main wall of the tracheostoma valve, wherein thehinging means of the circumferential bordering edge comprises an area ofthe main wall having locally reduced wall thickness. In this way, thehinging means are, so to speak, implicitly formed by at least part ofthe bordering edge of the bistable wall portion. This furthercontributes to the simplicity, compactness and softness of thetracheostoma valve.

Preferably, in operation, the bistable wall portion is arranged suchthat it is accessible for being touched by a user's finger. Thus, thetracheostoma valve is switchable from the breathing condition into thespeaking condition not only in response to a spurt of inhalation air,but also in response to manually pushing the bistable wall portion fromthe second stable position into the first stable position. Furthermore,when the tracheostoma valve is in its speaking condition and the userwants to speak very loud, the user then is able to prevent anundesirable switching into the breathing condition by manually retainingthe bistable wall portion in the first stable position.

Preferably, at least the main air passage structure comprises filteringmeans arranged for being moisturised by exhalation air and thus formoisturising inhalation air. This assures that inhaled air via thetracheostoma valve has approximately the same humidity as air that isinhaled via upper respiratory ways. Hence, the filtering means functionsas an “artificial nose”. The filtering means may for example be a foammaterial, e.g. foamed polyurethane impregnated with calcium chloride.

In a preferable embodiment of the invention, the tracheostoma valvefurther comprises a bypass air passage structure provided with a one-waybypass valve arrangement which, at least in said speaking condition,allows air inhalation via the bypass air passage structure, but preventsair exhalation via the bypass air passage structure. This bypass airpassage structure and one-way bypass valve arrangement provide anability to inhale during phonation, allowing the patient to extend theduration of speech indefinitely. Hence, this known inhalation valve canautomatically stay in the speaking condition until the patientdeliberately changes it into the breathing condition.

Preferably, the one-way bypass valve arrangement comprises a first wallportion having at least one bypass opening therein, and a second wallportion forming an at least partly flexible flap, which flap in responseto pressure of exhalation air is being pressed against the first wallportion such that the at least one bypass opening is blocked by saidsecond wall portion for said preventing of air exhalation via the bypassair passage structure, and which flap in response to pressure ofinhalation air is being released from said at least one bypass openingfor said allowing of air inhalation via the bypass air passagestructure. Such a first wall portion and second wall portion are asimple, soft and reliable way of realizing the one-way bypass valvearrangement.

Preferably, the first wall portion and the second wall portion areintegrated parts of the at least partly flexible main wall of thetracheostoma valve. This further contributes to the compactness of thetracheostoma valve.

In a preferable embodiment of the invention, the tracheostoma valvefurther comprises an attachment device for attaching and connecting,respectively, the tracheostoma valve to a patient's neck andtracheostoma, respectively, wherein the attachment device comprises aflexible layer structure having a stoma opening therein, the flexiblelayer structure being arranged for attachment to the patient's neck suchthat the stoma opening is at the location of the patient's tracheostoma,and a circumferential flange attached to the flexible layer structure,said flange being arranged for connecting the attachment device to otherparts of the tracheostoma valve. For said attaching of the attachmentdevice to the patient's neck, it is for example possible that anattachment surface of the flexible layer structure is pre-applied with asuitable adhesive means. Such adhesive means may for example be coveredwith a foil which can be released from the adhesive means by the patientfor exposing the adhesive means for enabling the attachment.

Preferably, the flexible layer structure comprises at least a layerportion that substantially has a funnel shape discharging into the stomaopening, and wherein a circumferential attachment area where theflexible layer structure is attached to the circumferential flange issituated at a distance from a circumferential edge of the stoma openingsuch that part of said funnel shape extends between said circumferentialattachment area and said circumferential stoma opening edge. The funnelshape results in good conformance to the neck and tracheostoma,especially in cases where the patient has a relatively deeptracheostoma. The part of the funnel shape that extends between saidcircumferential attachment area and said circumferential stoma openingedge prevents tunnelling of air flow between the neck skin and theflexible layer structure and thus prevents air leakeage, peeling of theflexible layer structure and consequent dislodgement of the attachmentdevice from the patient's neck.

It is remarked that an attachment device for attaching and connecting,respectively, a tracheostoma valve to a patient's neck and tracheostoma,respectively, wherein:

-   -   the attachment device comprises a flexible layer structure        having a stoma opening therein, the flexible layer structure        being arranged for attachment to the patient's neck such that        the stoma opening is at the location of the patient's        tracheostoma, and a circumferential flange attached to the        flexible layer structure, said flange being arranged for        connecting the attachment device to other parts of the        tracheostoma valve; and    -   the flexible layer structure comprises at least a layer portion        that substantially has a funnel shape discharging into the stoma        opening, and wherein a circumferential attachment area where the        flexible layer structure is attached to the circumferential        flange is situated at a distance from a circumferential edge of        the stoma opening such that part of said funnel shape extends        between said circumferential attachment area and said        circumferential stoma opening edge;

may, with similar effects and advantages, be used with or be part ofother types of tracheostoma valves than just the tracheostoma valveshaving the features disclosed herein. Such an attachment device may, forexample, be used with or be part of various other types of “inhalationvalves” and also of various types of “exhalation valves”.

BRIEF DESCRIPTION OF THE DRAWINGS

Further details, aspects and embodiments of the invention will bedescribed, by way of example only, with reference to the schematicfigures in the enclosed drawing.

FIG. 1 shows, in perspective view, an example of an embodiment of anassembled tracheostoma valve according to the invention, thetracheostoma valve being in its breathing condition.

FIG. 2 shows, in perspective view, the tracheostoma valve of FIG. 1 in adisassembled condition.

FIG. 3 shows a perspective view at some cross-sected parts of thetracheostoma valve of FIG. 1, the bistable wall portion being in itssecond stable position in which the tracheostoma valve is in itsbreathing condition.

FIG. 4 shows the cross-sected parts of FIG. 3 in similar view, howeverwith the bistable wall portion being in its first stable position inwhich the tracheostoma valve is in its speaking condition.

FIG. 5 shows, in perspective view, the attachment device of thetracheostoma valve of FIG. 1.

FIG. 6 shows a perspective view at the attachment device of FIG. 5, whencross-sected.

DETAILED DESCRIPTION

FIGS. 1 and 2 show an example of an embodiment of a tracheostoma valve 1according to the invention. The shown tracheostoma valve 1 comprises acap 2, a filtering means 3, a cap seat 4 and an attachment device 5.Note that, for simplicity, the filtering means 3 is not shown in FIGS. 3and 4.

The cap 2 comprises a flexible main wall which has a general shape whichis more or less like the shape of a dome. The flexible main wallcomprises wall portions 22, 24, 25, wherein the wall portion 25 has acircumferential connection flange 26 (see FIGS. 3 and 4) for connectingthe cap 2 to the cap seat 4. The wall portion 25 has a number ofbreathing openings 21 therein. In the shown example, some of thebreathing openings 21 are situated relative to one another atcircumferentially spaced apart locations. The shown filtering means 3,for example a foam material, is substantially ring shaped and, inoperation, is coaxially placed in the dome shaped cap 2. The cap seat 4comprises a circumferential, flexible cap seat wall comprising wallportions 44, 45, 46. The wall portion 46 has two circumferentialconnection flanges 47 and 48 arranged for co-operation with theconnection flange 26 of the cap 2 for interconnecting the cap 2 and thecap seat 4, see FIGS. 3 and 4. As shown in FIGS. 3 and 4, the flexiblecap seat wall furthermore forms an air passage way 42 and orifice 41.Also, the wall portion 46 forms a circumferential recess 49. Theattachment device 5 comprises a circumferential flange 53 arranged forco-operation with the circumferential recess 49 of the cap seat 4 forinterconnecting the cap seat 4 and the attachment device 5. As shown inFIGS. 5 and 6, the attachment device 5 further comprises a flexiblelayer 52 having a stoma opening 51 therein.

The openings 21, the filtering means 3, the orifice 41, the air passageway 42 and the stoma opening 51 are part of the main air passagestructure of the tracheostoma valve 1. The main valve arrangement of thetracheostoma valve 1 comprises the two wall portions 22, 24 of the cap2, which two portions together form a flexible bistable wall portionwhich has a circumferential bordering edge 23. The circumferentialbordering edge forms a hinging means 23 around which the bistable wallportion 22, 24 is hingeable between a first stable position and a secondstable position. In the first stable position (shown in FIG. 4) theclosed position of the main valve arrangement is attained in that theorifice 41 is being blocked by the bistable wall portion 22, 24. In thesecond stable position (shown in FIG. 3) the open position of the mainvalve arrangement is attained in that the bistable wall portion 22, 24is releasing the orifice 41.

By means of the main air passage structure 21, 3, 41, 42, 51 and themain valve arrangement 22, 23, 24, 41, the tracheostoma valve 1 isswitchable in response to a spurt of inhalation air from the breathingcondition into the speaking condition, while the tracheostoma valve isswitchable in response to a spurt of exhalation air from the speakingcondition into the breathing condition. The mechanisms responsible forsuch switchings are as follows. A spurt of inhalation air in thebreathing condition of FIG. 3 causes an underpressure on the interiorside of the bistable wall portion 22, 24 relative to the (higher)pressure on the exterior side of the bistable wall portion. Theresulting pressure difference causes the bistable wall portion to hingefrom its second stable position shown in FIG. 3 into its first stableposition shown in FIG. 4. On the other hand, a spurt of exhalation airin the speaking condition of FIG. 4 causes an overpressure on theinterior side of the bistable wall portion relative to the (lower)pressure on the exterior side of the bistable wall portion. Theresulting pressure difference causes the bistable wall portion to hingefrom its first stable position shown in FIG. 4 into its second stableposition shown in FIG. 3.

In the shown example, the bistable wall portion 22, 24 is an integratedpart of the flexible main wall 22, 24, 25, wherein the hinging means 23of the circumferential bordering edge 23 comprises an area of the mainwall 22, 24, 25 having locally reduced wall thickness.

In the shown example, the bistable wall portion 22, 23, 24 is arrangedsuch that it is accessible for being touched by a user's finger.

The tracheostoma valve 1 further comprises a bypass air passagestructure provided with a one-way bypass valve arrangement which, atleast in said speaking condition, allows air inhalation via the bypassair passage structure, but prevents air exhalation via the bypass airpassage structure.

The one-way bypass valve arrangement comprises a first wall portion, inthe form of the abovementioned wall portion 44, and a second wallportion, in the form of the abovementioned wall portion 45. The firstwall portion 44 has a number of bypass openings 43 therein. The bypassopenings 43 may for example be situated relative to one another atcircumferentially spaced apart locations of the first wall portion 44.The second wall portion 45 forms an at least partly flexible flap. Inresponse to pressure of exhalation air, the flap 45 is being pressedagainst the first wall portion 44 such that the at least one bypassopening 43 is blocked by the flap 45 for said preventing of airexhalation via the bypass air passage structure. In response to pressureof inhalation air, the flap 45 is being released from said at least onebypass opening 43 for allowing air inhalation via the bypass air passagestructure.

Some more detailed aspects of the circumferential flexible cap seat wallcomprising the wall portions 44, 45 and 46, as used in the shownexample, are explained as follows. At first, it is remarked that thisflexible cap seat wall has been manufactured as a single integratedpiece, for example by moulding. This contributes considerably to thesimplicity of the tracheostoma valve. It can be seen from FIGS. 3 and 4that the wall thickness of the second wall portion 45 is smaller thanthe wall thickness of the wall portions 44 and 46. Also, FIGS. 3 and 4show that the orifice 41 is formed by a folding area of the second wallportion 45. That is, the second wall portion 45 was moulded in unfoldedcondition and, after it was moulded, was folded-back at said foldingarea. This folding-back operation has created, at the location of theborder of the orifice 41, a circumferential air chamber enveloped by thefolded-back folding area of the second wall portion 45. The folding areawith enveloped air chamber functions as a resilient sealing means forthe first stable position of the bistable wall portion 22, 24 in whichthe closed position of the main valve arrangement is attained in thatthe orifice 41 of the main passage structure is being blocked, see FIG.4. Note that in FIG. 4 the folded-back folding area is received in acircumferential groove 27 formed by the shown living hinge 27 betweenthe wall portions 22 and 24 of the bistable wall portion. Said resilientsealing means takes care that, in the shown speaking condition of FIG.4, a sealing engagement is preserved during moderate movements of thebistable wall portion resulting for example from moderate overpressureson the interior side of the bistable wall portion occurring duringnormal speaking conditions (hence without producing a spurt ofexhalation air). Thus, in fact, the resilient sealing means provide asealing engagement that remains effective during slight movements of thebistable wall portion 22, 24. Note that, at the locations 28 indicatedin FIGS. 3 and 4, the second wall portion 45 may for example have acircumferential ridge that may be received in a circumferential groovein the first wall portion 44 for keeping the folded-back folding area ofthe first wall portion 45 in place under varying speaking pressures.

As mentioned, the tracheostoma valve according to the invention furthercomprises the attachment device 5 for attaching and connecting,respectively, the tracheostoma valve 1 to a patient's neck andtracheostoma, respectively, wherein the attachment device comprises aflexible layer structure 52 having a stoma opening 51 therein, theflexible layer structure being arranged for attachment to the patient'sneck such that the stoma opening is at the location of the patient'stracheostoma, and a circumferential flange 53 attached to the flexiblelayer structure 52, said flange being arranged for connecting theattachment device 5 to other parts of the tracheostoma valve 1. In theshown example, the flexible layer structure is formed by the singleflexible layer 52. Preferably, the circumferential flange 53 is rigid orat least less flexible than the flexible layer 52. It is remarked thatinstead of the single layer 52, the flexible layer structure may alsohave a multilayer structure. Furthermore, it is remarked that theplanform of the shown flexible layer 52 may have various forms, such ascircular, elliptical, etcetera. In the shown example, the planform hasan “egg-like” shape, intended to be placed on the patient's neck in anorientation in which the “top of the egg” is pointing towards thepatient's head.

In FIGS. 5 and 6 it can be seen that the flexible layer 52 comprises atleast a layer portion that substantially has a funnel shape discharginginto the stoma opening 51, and that a circumferential attachment area 54where the flexible layer structure is attached to the circumferentialflange 53 is situated at a distance from a circumferential edge 55 ofthe stoma opening 51 such that part of said funnel shape extends betweensaid circumferential attachment area 54 and said circumferential stomaopening edge 55.

In the foregoing specification, the invention has been described withreference to specific examples of embodiments of the invention. It will,however, be evident that various modifications and changes may be madetherein without departing from the broader scope of the invention as setforth in the appended claims.

For example, in the shown example, the full bistable wall portion isflexible. It is however possible to apply a bistable wall portion whichalso has non-flexible parts. Furthermore, in the shown example, theopenings 21 are not intersecting the circumferential bordering edge 23.Instead, such intersecting may be possible, in which case only the notintersected parts of the circumferential bordering edge 23 form hingingmeans. Also, in the shown example, in the first stable position (shownin FIG. 4) the closed position of the main valve arrangement is attainedin that the orifice 41 is being blocked by direct abutting contact ofthe bistable wall portion 22, 24 against the boundary of the orifice 41.Instead, indirect blocking of the orifice is possible, for example inthat the bistable wall portion in its first stable position provides forblocking of the orifice via a separate other element of the main valvearrangement.

Furthermore, the cap and cap seat may be integrally manufactured, forexample in the form of a single, circumferential flexible wall, in whichcase the flanges 26, 47 and 48 are not necessary anymore. Similarly, theattachment device may be integrally manufactured with the cap seat (andcap).

The flexible character of its parts makes the tracheostoma valvefoldable, which is convenient for many purposes, for example for storagein a ladies handbag, for facilitating the interchanging of the filteringmeans, or for machine washing together with clothing. The totaltracheostoma valve may for example be made flexible, or it may be madetotally flexible apart from a stiff circumferential flange of theattachment device.

Also, the cap may have various other shapes than the shown dome shape.

The flexible wall(s)/layer(s) used in a tracheostoma valve according tothe invention may be made of various materials, for example elastomericmaterials, such as silicone rubber. These flexible wall(s)/layer(s) mayhave various, locally varying thickness distributions, in which localthicknesses may generally be very small, such as in the order of lessthan 1.0 millimeters or less than 0.5 millimeters or less than 0.2millimeters.

However, other modifications, variations and alternatives are alsopossible. The specifications and drawings are, accordingly, to beregarded in an illustrative rather than in a restrictive sense.

1. An attachment device for attaching and connecting, respectively, atracheostoma valve to a patient's neck and tracheostoma, the attachmentdevice comprising: a flexible layer structure having a stoma openingtherein, the flexible layer structure being arranged for attachment tothe patient's neck such that the stoma opening is at a location of thepatient's tracheostoma; and a circumferential flange attached to theflexible layer structure, the flange being arranged for connecting theattachment device to the tracheostoma valve, wherein the flexible layerstructure comprises at least a layer portion that substantially has afunnel shape discharging into the stoma opening, and wherein acircumferential attachment area, where the flexible layer structure isattached to the circumferential flange, is situated at a distance from acircumferential edge of the stoma opening such that part of the funnelshape extends between the circumferential attachment area and thecircumferential edge of the stoma opening.
 2. The attachment deviceaccording to claim 1, wherein the flexible layer structure has aplanform comprising an egg-like shape.
 3. The attachment deviceaccording to claim 2, wherein: the egg-like shape comprises a narrow endand a broad end, and the attachment device is positioned on thepatient's neck such that the narrow end is pointing towards thepatient's head.
 4. The attachment device according to claim 1, wherein asurface of the flexible layer structure configured to contact thepatient's neck comprises a pre-applied adhesive.
 5. The attachmentdevice according to claim 1, wherein the tracheostoma valve isswitchable in response to a spurt of inhalation air from a breathingcondition into a speaking condition.
 6. The attachment device accordingto claim 1, wherein the tracheostoma valve is switchable in response toa spurt of exhalation air from a breathing condition into a speakingcondition.
 7. The attachment device according to claim 1, wherein theflexible layer structure comprises an elastomeric material.
 8. Anattachment device, comprising: a flexible layer structure comprising astoma opening and a layer portion that substantially has a funnel shapedischarging into the stoma opening, the flexible layer structure beingarranged for attachment to a patient's neck such that the stoma openingis at a location of the patient's tracheostoma; and a circumferentialflange attached to the flexible layer structure at a circumferentialattachment area, the circumferential flange being arranged forconnecting the attachment device to a tracheostoma valve, wherein thecircumferential attachment area is situated at a distance from acircumferential edge of the stoma opening such that part of the funnelshape extends between the circumferential attachment area and thecircumferential edge of the stoma opening.
 9. The attachment device ofclaim 8, wherein the flexible layer structure comprises a planformhaving an egg-like shape, the egg-like shape comprising a narrow end anda broad end.
 10. The attachment device of claim 9, wherein theattachment device is positioned on the patient's neck such that thenarrow end is pointing towards the patient's head.
 11. The attachmentdevice of claim 8, wherein a surface of the flexible layer structureconfigured to contact the patient's neck comprises a pre-appliedadhesive.
 12. The attachment device of claim 11, further comprising afoil configured to cover the surface of the flexible layer structurecomprising the pre-applied adhesive, the foil being releasable by thepatient to expose the adhesive to attach to the patient's neck.
 13. Theattachment device of claim 8, wherein the tracheostoma valve isswitchable in response to a spurt of inhalation air from a breathingcondition into a speaking condition.
 14. The attachment device of claim8, wherein the tracheostoma valve is switchable in response to a spurtof exhalation air from a breathing condition into a speaking condition.15. The attachment device of claim 8, wherein the flexible layerstructure comprises an elastomeric material.